A Trial to Understand How Safe and Well Tolerated ZP9830 is and How it Works in People With Plaque Psoriasis Over an 8-week Treatment Period

NCT07733089 | Recruiting Phase 1

• 3 other identifiers: ZP9830-252042026-525220-15-00WHO, UTN number
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to investigate the effects of repeated administration of ZP9830 for 8 weeks in participants with plaque psoriasis. Here, the primary aim is to evaluate safety and tolerability of ZP9830, the secondary aims are to test clinical efficacy and pharmacokinetics, and lastly the exploratory aim is to test the pharmacodynamic effects of ZP9830 treatment.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Adverse Events (TEAEs)

  To evaluate the safety and tolerability of ZP9830 following administration of multiple doses in participants with plaque psoriasis.

  From baseline (Day 1, predose) to follow-up (Day 85)

Study Arms (2)

ZP9830

EXPERIMENTAL

The experimental arm is divided into two treatment arms with different dose frequencies.

Drug: ZP9830

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ZP9830 DRUG

Participants will receive multiple doses of ZP9830. The dose frequency will depend on treatment arm

ZP9830

Placebo DRUG

Participants will receive multiple doses of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants with a confirmed diagnosis of psoriasis (stable plaque psoriasis ≥ 2 months).
• Participants who have ≥ 2 vulgar psoriatic plaques.
• BMI within the range 18.0-35.0 kg/m2 (inclusive).

You may not qualify if:

• Erythrodermic, predominantly guttate, exclusively palmar/plantar, or generalized pustular psoriasis.
• Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate).
• Any clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hematology, biochemistry, and urinalysis).
• Any clinically significant abnormal findings during the standardized neurological examination conducted at screening.
• Use of any concurrent systemic medications that could affect psoriasis or psoriasis evaluation, including corticosteroids, retinoids, cyclosporine, methotrexate, PDE4s (phosphodiesterase 4), or biologic agents within 30 days prior to IMP administration or planned to use during the course of the trial.
• Use of concurrent topical medications containing corticosteroids, retinoids, calcitriol or other topical medication relevant to psoriasis treatment (must be discontinued at least 2 weeks prior to baseline).
• Use of any biologic or advance systemic therapies for any autoimmune disease within the last 12 months.
• Use of UVA, PUVA, or UVB therapy and tanning beds within 4 weeks of baseline or during trial participation.

Sponsors & Collaborators

• Zealand Pharma: lead
• Centre for Human Drug Research, Netherlands: collaborator
• ICON Clinical Research: collaborator

Study Sites (1)

Centre for Human Drug Research

Leiden, South Holland, 2333 CL, Netherlands

RECRUITING

Central Study Contacts

Clinical Operations

CONTACT

+45 88 77 36 00; clinicaltrials@zealandpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 29, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)